FDA：缬沙坦药品实验室分析

 翻译：JULIA  来源： Julia法规翻译

Laboratory analysis of valsartan products

缬沙坦药品实验室分析

FDA continues to investigate the presence ofimpurities in valsartan and other angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure. FDA has identified the impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in ARB active pharmaceutical ingredient (API) and finished drugs. Medicines with confirmed levels of NDMA or NDEA exceeding the interim acceptable intake limits have been recalled because they pose an unacceptable safety risk to patients.

FDA持续调查缬沙坦和其它用于治疗高血压和心力衰竭的ARB中杂质情况。FDA已在ARB活性药物成分（API）和制剂中识别出NDMA和NDEA杂质。由于对患者有不可接受的安全性风险，凡经确认NDMA或NDEA超出临时可接受摄入限度的药品已召回。

FDA is posting additional test results in the table below showing NDMA and NDEA levels in recalled valsartan. The analyses reflect average levels of the impurities present in a single tablet based on the strength of the tested medicines within the lots tested, which are identified in the table. The table provides NDMA and NDEA levels and indicates where impurities either were not present or were below the limit of detection (LOD) of our testing method.  Some of the medicines listed below may have been repackaged by other companies as noted in FDA’s list of recalled ARBs.

FDA在下表中发布已召回缬沙坦中NDMA和NDEA检测结果。分析结果显示了根据已召回药品批次中所测药品剂量计算的单片中检出的杂质水平平均值。该表给出的NDMA和NDEA水平，如果未检出杂质或低于我们检验方法检出限（LOD）时亦标出。下列有些药品可能经过其它公司重新包装，在FDA的ARB召回清单中有说明。

Based on FDA laboratory testing results and records from manufacturers of the recalled valsartan lots, the impurities may have been present in valsartan-containing finished drug lots for up to four years. FDA based the estimates below on the highest daily dose; however, many people may have taken lower doses, and therefore, their risks would theoretically be less. FDA expects the actual cancer risk to most consumers to be lower than ourestimate. For reference, consuming up to 0.096 micrograms of NDMA or 0.0265 micrograms of NDEA per day is considered reasonably safe for human ingestion based on lifetime exposure.

根据FDA实验室检测结果和被召回缬沙坦批次的生产商记录，含缬沙坦的制剂批次中出现的杂质可能已持续达4年。FDA根据以下对最高日剂量做出估算，当然许多人可能摄入更低剂量，因此其风险理论上来讲会更低。FDA预期大多消费者的实际患癌风险低于我们的估算。作为参考，在一生中每天消耗达0.096μg的NDMA或0.0265μg的NDEA可合理认为是对人体消化来说是安全的。

NDMA ESTIMATED RISK: NDMA预估风险

FDA estimated that if 8,000 people took the highest valsartan dose (320 mg) containing NDMA from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of the 8,000 people.

FDA估算如果8000人摄入所召回批次中含NDMA最高缬沙坦剂量（320mg）达4年，则8000人中可能增加一例患癌风险。

NDEA ESTIMATED RISK NDEA预估风险

FDA scientists estimate that if 18,000 people took valsartan at the highest dose (320 mg) containing NDEA from recalled batches daily for four years, there may be one additional case of cancer over the lifetime of these 18,000 people. NDEA has a marginally lower cancer risk estimate than NDMA because NDEA levels were lower than levels of NDMA in drug samples.

FDA科学家估算如果18000人摄入所召回批次中含NDEA最高缬沙坦剂量（320mg）达4年，则18000人中可能增加一例患癌风险。由于NDEA水平低于药品样本中NDMA的水平，因此NDEA的癌症风险估算略低于NDMA。